510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K172305Substantially Equivalent

CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump

Datascope Corp., Manwah NJ / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K172305 is the FDA 510(k) clearance record for CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump, a class II device, cleared for Datascope Corp. on under FDA product code DSP (System, Balloon, Intra-Aortic And Control). FDA records list 139 510(k) clearances for Datascope Corp., from to . As of , FDA records show 2 recalls naming K172305.

Clearance record

Decision date
Received
(73 days to decision)
Product code
DSP System, Balloon, Intra-Aortic And Control
Regulation
21 CFR 870.3535
Device class
Class II
Review panel
Cardiovascular
Applicant
Datascope Corp. 1300 Macarthur Blvd., Manwah NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DSP

Trailing 12 months

FDA records hold no clearances under product code DSP in the trailing twelve months.

FDA records show no clearances under product code DSP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DSP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260